Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial.

Hdl Handle:
http://hdl.handle.net/10147/317077
Title:
Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial.
Authors:
Valkenet, Karin; Trappenburg, Jaap CA; Gosselink, Rik; Sosef, Meindert N; Willms, Jerome; Rosman, Camiel; Pieters, Heleen; Scheepers, Joris JG; de Heus, Saskia C; Reynolds, John V; Guinan, Emer; Ruurda, Jelle P; Rodrigo, Els HE; Nafteux, Philippe; Fontaine, Marianne; Kouwenhoven, Ewout A; Kerkemeyer, Margot; van der Peet, Donald L; Hania, Sylvia W; van Hillegersberg, Richard; Backx, Frank JG
Is Part Of:
Trials
Citation:
Valkenet K et al. Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial. Trials. 2014 Apr 27;15(1):144
Issue Date:
27-Apr-2014
URI:
http://dx.doi.org/10.1186/1745-6215-15-144; http://hdl.handle.net/10147/317077
Abstract:
Abstract Background Esophageal resection is associated with a high incidence of postoperative pneumonia. Respiratory complications account for almost half of the readmissions to the critical care unit. Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs. In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay. While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection, the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical populations other than cardiac surgery in a randomized and controlled study design. Methods/Design The effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter randomized controlled trial (the PREPARE study). In total 248 patients (age >18 years) undergoing esophageal resection for esophageal cancer will be included in this study. They are randomized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device. Patients have to complete 30 dynamic inspiratory efforts twice daily for 7 days a week until surgery with a minimum of 2 weeks. The starting training load will be aimed to be 60% of maximal inspiratory pressure and will be increased based on the rate of perceived exertion.The main study endpoint is the incidence of postoperative pneumonia. Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay, duration of mechanical ventilation, incidence of other postoperative (pulmonary) complications, quality of life, and on postoperative respiratory muscle function and lung function. Discussion The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection. Trial registration NCT01893008.
Item Type:
Article
Language:
en
Keywords:
OESOPHAGEAL CANCER; SURGERY
Local subject classification:
ADVERSE EFFECTS

Full metadata record

DC FieldValue Language
dc.contributor.authorValkenet, Karinen_GB
dc.contributor.authorTrappenburg, Jaap CAen_GB
dc.contributor.authorGosselink, Riken_GB
dc.contributor.authorSosef, Meindert Nen_GB
dc.contributor.authorWillms, Jeromeen_GB
dc.contributor.authorRosman, Camielen_GB
dc.contributor.authorPieters, Heleenen_GB
dc.contributor.authorScheepers, Joris JGen_GB
dc.contributor.authorde Heus, Saskia Cen_GB
dc.contributor.authorReynolds, John Ven_GB
dc.contributor.authorGuinan, Emeren_GB
dc.contributor.authorRuurda, Jelle Pen_GB
dc.contributor.authorRodrigo, Els HEen_GB
dc.contributor.authorNafteux, Philippeen_GB
dc.contributor.authorFontaine, Marianneen_GB
dc.contributor.authorKouwenhoven, Ewout Aen_GB
dc.contributor.authorKerkemeyer, Margoten_GB
dc.contributor.authorvan der Peet, Donald Len_GB
dc.contributor.authorHania, Sylvia Wen_GB
dc.contributor.authorvan Hillegersberg, Richarden_GB
dc.contributor.authorBackx, Frank JGen_GB
dc.date.accessioned2014-05-16T14:18:31Z-
dc.date.available2014-05-16T14:18:31Z-
dc.date.issued2014-04-27-
dc.identifier.citationValkenet K et al. Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial. Trials. 2014 Apr 27;15(1):144en_GB
dc.identifier.urihttp://dx.doi.org/10.1186/1745-6215-15-144-
dc.identifier.urihttp://hdl.handle.net/10147/317077-
dc.description.abstractAbstract Background Esophageal resection is associated with a high incidence of postoperative pneumonia. Respiratory complications account for almost half of the readmissions to the critical care unit. Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs. In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay. While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection, the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical populations other than cardiac surgery in a randomized and controlled study design. Methods/Design The effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter randomized controlled trial (the PREPARE study). In total 248 patients (age >18 years) undergoing esophageal resection for esophageal cancer will be included in this study. They are randomized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device. Patients have to complete 30 dynamic inspiratory efforts twice daily for 7 days a week until surgery with a minimum of 2 weeks. The starting training load will be aimed to be 60% of maximal inspiratory pressure and will be increased based on the rate of perceived exertion.The main study endpoint is the incidence of postoperative pneumonia. Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay, duration of mechanical ventilation, incidence of other postoperative (pulmonary) complications, quality of life, and on postoperative respiratory muscle function and lung function. Discussion The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection. Trial registration NCT01893008.-
dc.language.isoenen
dc.relation.ispartofTrials-
dc.subjectOESOPHAGEAL CANCERen_GB
dc.subjectSURGERYen_GB
dc.subject.otherADVERSE EFFECTSen_GB
dc.titlePreoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial.en_GB
dc.typeArticleen
dc.language.rfc3066en-
dc.rights.holderKarin Valkenet et al.; licensee BioMed Central Ltd.-
dc.description.statusPeer Reviewed-
dc.date.updated2014-05-13T23:05:49Z-
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